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A First-in-human Study of S230815 in Pediatric Participants With KCNT1-related Developmental and Epileptic Encephalopathy

Study acronym: KANDLE
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 7 wordsv8 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 16 to 15v7
  3. Site details revised at 1 of 16 sitesv6
  4. Site details revised at 4 of 16 sitesv5
  5. Start date: Sep 15, 2025 to Nov 24, 2025 Study sites: 13 to 16 · Primary and study completion dates: Apr 3, 2028 to Apr 15, 2028v4 Show 2 more changesShow less
    • Study sites: 13 to 16
    • Primary and study completion dates: Apr 3, 2028 to Apr 15, 2028
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 7 to 13v3
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 7 · Start date changed from estimate of Nov 2025 to Sep 15, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 7
    • Start date changed from estimate of Nov 2025 to Sep 15, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Study CL1-230815-001 (KANDLE) is a Phase Ib/II, First In Human, multicentre, open-label, multiple ascending dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effect of S230815 in pediatric participants with KCNT1-related Developmental Epileptic Encephalopathy. To participate in the study, participants must have a diagnosis of Developmental Epileptic Encephalopathy due to a documented pathogenic or likely pathogenic variant in KCNT1 (to be confirmed by central genetic testing at the screening visit). The study consists of a screening period followed by two consecutive interventional parts. Part 1 will evaluate multiple ascending doses of S230815. Part 2 is a long-term treatment extension for participants who have completed Part 1. Participants will seamlessly roll-over from Part 1 to Part 2, resuming the same cohort as they were assigned in Part 1, and will receive S230815 for a maximum of 72 weeks.
Trial Details
NCT Number NCT07227857
Lead Sponsor Institut de Recherches Internationales Servier
Conditions Epileptic Encephalopathy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov